Manager, Regulatory Affairs

Manager, Regulatory Affairs

Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage process from inception to approval. Establish and implement global regulatory strategies with cross-functional teams to assure compliance and approval. Ensure compliance with regulatory requirements for products which will include marketing, labeling, and literature review.

• Ensure all applicable regulations and standards and changes to these are communicated throughout the organization through company policies, procedures, and training
• Develop regulatory approval strategies to meet business objectives
• Review and approve marketing applications as needed prior to submission to regulatory bodies
• Ensure that all labeling, marketing literature, and internal policies and procedures are reviewed for compliance to regulatory requirements
• Ensure that all changes to products and processes (including additions and deletions) are reviewed for compliance to regulations and significant changes are communicated to the applicable regulatory body prior to implementation
• Participate in the preparation of Regulatory Affairs operating plans and objectives in alignment with company and departmental strategies
• Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management
• Remain current with new product development projects in order to ensure regulatory requirements are considered and appropriate strategies developed
• Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff
• Manage consultants and their contracts for assigned regulatory projects
• Ensure that departmental Standard Operating Procedures (SOP's) are developed, implemented, and maintained
• Review Quality System procedures for regulatory impact
• Prepare and manage budget for the Regulatory Affairs department
• Participate in continuous improvement activity and process re-engineering projects

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Qualifications/Work Experience

• 10 years experience in medical device regulatory function
• Demonstrated 510(k), PMA organization, preparation, and review experience
• Understanding of the device listing and establishment registration process
• EU MDD 93/42/EEC/ISO Technical File/Design Dossier (original/revision/supplements) organization, preparation, and review experience
• Experience with communication to FDA, EU, Japanese PMDA, and other regulatory bodies
• Demonstrated experience in interacting with FDA review staff and inspectors, Notified Bodies and international reviewers/inspectors
• Prefer experience in a team based work environment
• Demonstrated interpersonal, written, oral, communication, organizational and planning skills
• Demonstrated knowledge of MS office suite (Word, PowerPoint, Excel) and MS Access.
• Demonstrated ability to lead diverse team and team members in remote locations
• Demonstrated understanding of scientific principles

Education and/or Special Training

Bachelor's Degree in Scientific Discipline or equivalent, Prefer Advanced Degree; Prefer Regulatory Affairs Certification

Percent Travel Required

5-10%